Medical Device Development: A Regulatory Overview

Catalog description

Analyzes U.S. medical device engineering development, marketing approval, and commercialization compliance requirements from scientific, technical, and engineering-based perspectives. Features analysis of quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act (FDAMA). Provides a step-by-step guide through the Center for Devices and Radiological Health (CDRH). Covers CDRH's reengineering initiatives and evolving investigational device exemptions, premarket approval, 510(k) application process, and product development protocol and review processes. Offers practical, in-depth analyses and didactic instruction on how emerging technical trends and the application of statistical modeling to analyze product complaints are reshaping medical device regulation in the United States. Offers students an opportunity to learn how to think critically about the interaction between regulatory and development processes.